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A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

NCT05359081•Sumitomo Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.

Detailed Description

A phase 3, 52-week, open-label study to evaluate the long-term safety and tolerability of SEP-363856 in patients with schizophrenia in Japan. Participants will take flexible dose of SEP-363856 (50 mg/day and 75 mg/day) every night at bedtime for 52 weeks in an open-label manner.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.
•2. Male or female between 18 to 65 years of age (inclusive) at the time of consent.
•3. Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
•4. Must have a PANSS total score \>=60 at Screening and Baseline.
•5. Must have a CGI-S score \>=3 at Screening and Baseline
•6. Judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Baseline and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening
•7. In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination, vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis).

Exclusion Criteria

•1. Have a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder or substance (other than nicotine or caffeine) use disorder within past 12 months or for a total of \>= 10 years during the subject's lifetime, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment
•2. At significant risk of harming self, others, or objects based on Investigator's judgment.
•3. Have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
•4. Female subjects who are pregnant or lactating.
•5. Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.

Locations (51)

Hotei Hospital

Konan-shi, Aichi-ken, Japan

Heart Care Clinic Omachi

Akita, Akita, Japan

Seinan Hospital

Hachinohe-shi, Aomori, Japan

Ishigooka Hospital

Chiba, Chiba, Japan

Kohnodai Hospital National Center for Global Health and Medicine

Ichikawa-shi, Chiba, Japan

Fukui Hospital

Fukui-shi, Fukui, Japan

Ai Sakura Clinic

Fukuoka, Fukuoka, Japan

Inokuchi Noma Hospital

Fukuoka, Fukuoka, Japan

Kuramitsu Hospital

Fukuoka, Fukuoka, Japan

Medical corporation Shinseikai Kaku Mental Clinic

Fukuoka, Fukuoka, Japan

Key Dates

Start Date

May 16, 2022

Primary Completion Date

March 21, 2024

Completion Date

March 28, 2024

Last Updated

March 19, 2025

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

SEP-363856

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

Inclusion Criteria

Exclusion Criteria

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